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AstraZeneca has filed patent infringement actions in U.S. District Court, District of Delaware, against seven generic drug manufacturers, which have submitted abbreviated new drug applications (ANDAs) for Crestor.

On Nov. 1, AstraZeneca received a notice-letter from Cobalt Pharmaceuticals when it submitted its ANDA to the FDA, which sought approval to market generic versions of Crestor tablets prior to the expiration of patents covering Crestor tablets. Cobalt’s ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor, were not infringed or that the patents were otherwise invalid or unenforceable.

Each of the eight generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed U.S. patents referencing Crestor in the FDA’s Orange Book was not infringed or otherwise invalid or unenforceable.

Based on the various ANDA filings and Paragraph IV certifications, on Dec. 11, AstraZeneca filed individual patent infringement actions in U.S. District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314. AstraZeneca licenses the patent from Shionogi.